Co-Chairs’ Welcome Remarks

Trevor Wear
Partner
Sidley Austin LLP

Stephen Forster
Partner
Morgan Lewis Bockius LLP

The Politics and Policy of Post -IRA Prescription Drug Pricing Under Government Payor Programs

Matthew Wetzel
Partner
Goodwin Procter LLP

The IRA is significantly impacting the commercial landscape for prescription drugs, including drug development. Two of the most significant developments of the IRA include the Medicare drug price negotiation and the Medicare Part D redesign.

Points of discussion will include:

• Analyzing the impact of IRA reforms on the biopharmaceutical industry
• Review of first 10 drugs chose for negotiation process and why?
  • What will the criteria for the next group of drugs be?
• How does this play into the anticipated 2025 redesign for Part D
  • How would a new Administration in 2024 affect the redesign plan?

IRA Implementation State of the Union: A Look Back and A Look Forward into the First Round of Drug Price Negotiations

Trevor Wear
Partner
Sidley Austin LLP

Tiffany Frankson
Assistant General Counsel, Global Pricing and Health & Value
Pfizer

The first round of IRA implementation begins January 1, 2024. Join our speakers as they dive into the realities of the IRA implementation from early lessons learned to the anticipation of the challenges of round two. Topics to be discussed include:

• Understanding how drug prices will be negotiated under the IRA
  • Identifying what the current Administration and HHS are looking at in terms of negotiations?
  • What has the first round of negotiations revealed in terms of both the government’s and manufacturers’ expectations?
• Dissecting the IRA implementation process
  • How does it differ from negotiations in the pre-IRA era?
• Identifying key components that manufacturers need to keep in mind for successful negotiations
• Anticipating the next list of drugs that will be subject to the IRA and what their timelines will look like

Focus on Part D Manufacturer Discount Program

David J. Farber
Partner
King & Spalding (Washington, D.C.)

Robert J. Hill
Partner
Reed Smith LLP

• Identifying key differences with the Part D Manufacturer Discount Program and the Coverage Gap Discount Program
  • Exploring the criteria for whether a claim qualifies for no discount, 10% or 20%
• Analyzing the requirements for paying lower discounts as a “specified manufacturer” or “specified small manufacturer”
  • Evaluating how CMS will monitor for changes that could lead to a loss of such status  
• Understanding manufacturers’ contractual obligations to CMS
• Exploring manufacturer audit rights and parameters 

Morning Refreshment Break

Simplifying Inflation Rebate Penalties Under Medicare Part B and D

Mary L. Hendrickson
Partner
Foley & Lardner LLP

• Understanding IRA inflation rebate requirements for Part B drugs and its relationship to ASP
• Examining the IRA inflation rebate requirement for Part D drugs and its relationship to AMP
• Analyzing the benchwork periods for evaluating inflation for both existing and new drugs
• Evaluating what utilization is and is not subject to the rebate requirements
• Working through the mechanics of precisely how the rebates are calculated
• Exploring penalties for manufacturers who do not comply with new rebate provisions
• Looking at the impact and interplay of the IRA inflation rebates on commercial sales

Is it an Unlawful Taking? A Discussion of the Ongoing IRA Drug Price Negotiation Lawsuits

Toni-Ann Citera
Partner
Jones Day

T. Reed Stephens
Partner
Winston & Strawn LLP

In June of 2023, Merck filed its lawsuit against CMs over IRA drug negotiations alleging that this provision of the IRA is akin to an unlawful taking under the Fifth Amendment of the Constitution. Since that time Astra Zeneca, Boehringer Ingelheim, Bristol Myers Squibb, Johnson & Johnson, Novartis, and even PhRMA have filed similar lawsuits. Despite the filing of these suits, many of the plaintiff manufacturers are still participating in the IRA pricing negotiations. In this highly anticipated session as our speakers will provide an analysis of these suits and their significance:

• Overview of all the cases filed against the US government
  • What is still pending?
• Understanding what an unlawful taking is and why pharma companies claim that their constitutional rights are being infringed upon
• Analyzing the implications if pharmaceutical companies win
  • How will this change the IRA implementation
  • What are the benefits and consequences of this?
• Assessing the consequences if the US government wins the case
  • What does this mean for IRA implementation
  • Is it likely that the case will be appealed and ultimately go to SCOTUS?

Networking Luncheon

Unintended Consequences: Understanding the Fallout of the IRA on Government Payor Programs and the Private Sector

Merle DeLancey
Partner
Blank Rome LLP

James Kim
Partner
Arnold & Porter

• Analyzing the consequences of the IRA on other government drug payor programs:
  • Medicaid
  • PHS 340B
  • VA and DOD
• Understanding what the implications of the IRA are on the supply chain that inevitably affects cost and pricing
• Delving into how the private sector will be (or is) handling the IRA implementation
  • Exploring how the price of drugs will vary
  • Consequences for Medicare Advantage plans
• How will IRA- mandated pricing changes trickle through and affect the market to affect drug valuations as well as the economy

Afternoon Refreshment Break

A Look at PBMs through the Lens of the IRA: Practices and Their Legal Challenges

Margaux Hall
Partner
Ropes & Gray LLP

• Understanding the impact of the IRA on PBMs
• Exploring the ongoing case litigation involving PBMs
• Evaluating the FTC’s investigation on PBMs
• Assessing the shift towards PBM transparency and what this means for manufacturers
• Identifying best practices and strategies for negotiating with PBMs

Understanding How the Pricing of Biosimilars Affects Government Drug Payor Programs

Craig Bleifer
Partner
Akin Gump Strauss Hauer & Feld LLP

Samantha D. Marshall
Counsel
Hogan Lovells LLP

Congress passed legislation providing a pathway for biosimilars over a decade ago, and the widespread adoption of biosimilars has been slower than many policymakers would have liked. As a result, biosimilars enjoy many distinct and preferential treatments under the various government programs.

Points of discussion will include:

• Understanding how biosimilars are treated and impacted under each of the government pricing programs
  • Medicare
  • Medicaid
  • PHS 340B
• Identifying the impact biosimilars play in the Medicare Drug Price Negotiation process
• Evaluating why have stakeholders are hesitant to use available biosimilars
• Assessing the various measures currently in place at the federal and state level to encourage the movement to biosimilars
  • Forecasting the future of biosimilars and its impact on the government pricing programs

Day 1 Recap & Day 1 Adjourns

Co-Chairs’ Opening Remarks and Recap of Day 1

Stephen Forster
Partner
Morgan Lewis Bockius LLP

Trevor Wear
Partner
Sidley Austin LLP

Examining the Full Impact of CMS’ Ground-Shifting New Proposed Medicaid Drug Rebate Program Rule

Stephanie Trunk
Partner
Arent Fox Schiff LLP

• Reviewing how the 2023 MDRP proposed rule differs from the 2020 MDRP rule, currently in place
• Understanding how to identify best price and calculate URAs under the proposed rule
• Forecasting when the proposed rule will be finalized and what manufacturers will be required to follow
• Assessing the other significant impacts the proposed rule may cause
• Analyzing the possible legal challenges to the proposed rule
• Exploring the large provisions on the new process for audits
• What do manufacturers need to know

Morning Refreshment Break

Dissecting CMS’ New Guidance on Line Extensions

Chris Schott
Partner
Latham & Watkins LLP

• Understanding CMS’ new guidance on line extensions
  • How does this change things?
• Analyzing what the manufacturer release entails
  • What can manufacturers now do?

In-Depth Illustration of Medicaid Drug Pricing and Rebates

Melissa Wong
Partner
Holland & Knight LLP

• Exploring the components of Medicaid’s drug rebate system
  • Defining AMP and the AMP cap
  • What is “Best Price”?
• Outlining the formulas needed to determine unit rebate amounts
  • Unit rebate amount for brand drugs
  • Unite rebate amount for generic drugs
• Understanding the impact of price increases on unit rebate amounts
  • What is the baseline period for brand drugs?
  • What is the baseline period for generic drugs?
• Identifying line extensions and their impact on unit rebate amounts
• Dissecting manufacturer reporting requirements
  • What are the best practices?
• Analyzing the downstream effects on AMP, Best Price, and unit rebate amounts
• Answering how the IRA impacts Medicaid indirectly (dual-eligible)

PART I: An In-Depth Look at the Effects of the Genesis Case

Stephen Forster
Partner
Morgan Lewis Bockius LLP

Constance Wilkinson
Board of Directors/Member of the Firm
Epstein Becker & Green, P.C.

• Delving into what happened in the Genesis Case
• Assessing the new patient definition
• Understanding the effects of Genesis on the 340B program
• Analyzing best practices that counsel and manufacturers need to know to navigate the implications of the Genesis case

Networking Luncheon

PART II: Exploring Other Recent 340B Developments

Chris Hatwig
President
Apexus

Michelle S. Meyer
Senior Director, Consulting
Riparian LLC

• Examining the evolution of the PHS 340B program and recent developments
  • Defining and redefining 340B entities
  • Understanding how 340B pricing is calculated
• Analyzing specific state 340B legislation and related litigation
  • Arkansas
• Examining the new 340B ADR rule
  • Outlining the limitations on the scope of what can be litigated under the new rule
  • Timeline/Timeframe changes
• Exploring recent case law and its affect on the 340B program
  • American Hospital Association (AHA) v. Becerra
  • PhRMA 340B Case

Analyzing Present and Pending State Drug Transparency Laws

Stephen Forster
Partner
Morgan Lewis Bockius LLP

Trevor Wear
Partner
Sidley Austin LLP

This session will explore the rise of state transparency laws across the country and how they are working in conjunction with government payor programs.

• Identifying states with current and pending drug pricing transparency laws under:
  • Medicaid
  • Medicare
  • PHS 340B
• Assessing state drug price transparency reporting
• Understanding how states are using the information manufacturers report
• Addressing challenges with and finding solutions for reporting under non-uniform and sometimes conflicting state laws
  • Can a state request supplemental rebates within these models?
  • If the rebate is denied, can the state exclude the drug from Medicaid coverage?

Afternoon Refreshment Break

A Manufacturer’s Guide to Critical Drug Pricing and Reimbursement Considerations when Launching New Products

Sharon Small
Director, Counsel – Market Access-Gov.t Pricing and Policy
Novartis

Rujul H. Desai
Partner
Covington & Burling LLP

• Examining pricing and reimbursement considerations form the pre-commercialization through product launch stages
• Analyzing the procedural approaches to set a launch price for a new drug
• Understanding legal, policy, and reputational risks around price setting
• Ensuring transparency for the pricing process
• Considering the role of traditional and non-traditional functions in setting price
• Accessing government and commercial programs to secure appropriate coding, coverage, and reimbursement for new products
• Examining how the IRA is impacting the pricing of new products

Day 2 Recap
Conference Adjourns